山西医科大学学报2023，Vol.54Issue(11)：1529-1534,6.DOI:10.13753/j.issn.1007-6611.2023.11.016
不同绝对计数管在淋巴细胞亚群检测中Bland-Altman 一致性的评价
Bland-Altman agreement evaluation of lymphocyte subsets absolute counts using different absolute counting tubes
摘要
Abstract
Objective To evaluate the agreement of absolute counts of peripheral lymphocytes measured by domestic and imported absolute counting tubes.Methods Flow cytometry was applied for absolute counting of CD3+and CD3+CD4+lymphocyte in 80 peripheral blood samples using two domestic and one imported absolute counting tubes,respectively.The differences of the absolute counts detected by domestic and imported absolute counting tubes were analyzed by D'Agostino & Pearson test and regression analysis for randomness,covariance,and normality.The agreement and the correlation were analyzed using Bland-Altman method and linear regression,and the coefficient of variation was evaluated in quality control samples with both medium and low concentrations.Results The differences in the absolute counts of both CD3+and CD3+CD4+lymphocytes detected by two domestic and imported absolute counting tubes were confirmed to be non-standard data,and thus the ratios of results from different absolute counting tubes were analyzed by ratio Bland-Altman method.All the dots between 95％CIs of upper and lower limits of 95％limits of agreement(LoA)were within the clinically acceptable consistency boundary.Linear regression analysis showed that the absolute counts of CD3+and CD3+CD4+lymphocyte using two domestic and one imported absolute counting tubes were highly correlated,and the regression equations were established(P＜0.001).Repeated experiments using different absolute counting tubes were conducted on quality control samples of medium and low levels for 12 times.The results showed that the CV values for the median CD3+and CD3+CD4+lymphocyte abso-lute counts were not more than 4.13％,while the CV values of low CD3+and CD3+CD4+lymphocyte absolute counts were not more than 6.86％,indicating good reproducibility.Conclusion The absolute counts of peripheral CD3+and CD3+CD4+lymphocyte are consistent between domestic and imported absolute counting tubes.Domestic products can be used to replace imported ones in clinical laboratories according to their demand.关键词
绝对计数管/淋巴细胞亚群/Bland-Altman分析/线性回归/流式细胞术Key words
absolute count tube/lymphocyte subsets/Bland-Altman method/linear regression/flow cytomety分类
医药卫生引用本文复制引用
张晰,王增国,张越,郭贤,曹媛,李丹,段明玥..不同绝对计数管在淋巴细胞亚群检测中Bland-Altman 一致性的评价[J].山西医科大学学报,2023,54(11):1529-1534,6.基金项目
国家自然科学基金项目(82172312) （82172312）
陕西省自然科学基础研究计划项目(2022JM-480) （2022JM-480）
西安市创新能力强基计划医学研究项目(21YXYJ0011) （21YXYJ0011）
